The gum resin of the plant Boswellia serrata (Burseraceae) has long been in use for the treatment of rheumatoid arthritis and gout by the practitioners of Ayurvedic medicines in the Indian system of medicine. Various extracts of the gum resin have shown potent anti-inflammatory and anti-atherogenic activity in laboratory animals [Cuaz-Pérolin et al., Arterioscler Thromb Vasc Biol February 2008]. Incensole acetate a Boswellia compound isolated was proved to be a NFκB inhibitor and useful as anti-inflammatory compound. [Moussaieff et al., Mol Pharmacol 72,1657-1664, 2007]. It was observed in the past that the ethanolic extract of the gum resin of B. serrata inhibits the formation of Leukotriene B4 in rat peritoneal neutrophils. Leukotriene B4 is one of the important mediators of inflammatory reactions [Ammon, H. P. T. et al., Planta Medica, 57, 203 (1991)]. The extract of Boswellia was found to be a potent anti-arthritic agent [Kimmatkar et al; Phytomedicine. 2003 January; 10(1):3-7.], and immunomodulatory agent [Pungle et al; Indian J Exp Biol. 2003 December; 41(12):1460-1462]. The cholesterol lowering action of Boswellia serrata was also proved. [Zutshi U et al, Indian J Pharmac. 18, 182-183, 1986.]. In fact, a randomized, double blind, placebo controlled, crossover clinical trial with Boswellia extract on a group of patients with osteoarthritis of knee exhibited statistically significant mean improvements with respect to reduction in pain, decreased swelling and increased knee flexion [Kimmatkar N, et. al., Phytomedicine 2003; 10: 3-7]. In an open non-randomized equivalence study, 30 patients with chronic colitis were administered either Boswellia gum (300 mg thrice daily) or sulfasalazine (1 g thrice a day) and the therapeutic effects shown by Boswellia were comparable to those exhibited by sulfasalazine [Gupta I, et. al., Planta Med. 2001; 67: 391-395]. In another equivalency study, Boswellia standardized extract exhibited therapeutic improvements, comparable to, or better than, mesalazine in a randomized, double-blind study on patients with active Crohn's disease [Gerhardt H, et. al., Z Gastroenterol 2001; 39: 11-17]. Boswellia gum resin also showed statistically significant improvement in patients with bronchial asthma in a six-week double-blind, placebo controlled study [Gupta I, et. al., Eur J Med Res 1998; 3: 511-51].
The patents also describe various activities of Boswellia. Some are quoted below:
PCT Patent publication WO03074063A1 and granted Indian patent #205269 relates to a process for producing a fraction enriched upto 100% of 3-O-acetyl-11-keto-β-boswellic acid. An organic solvent extract of gum resin from Boswellia species is first subjected to oxidation and then acetylation or vice versa. This converts the less potent boswellic acids present in the fraction to AKBA. This treated fraction is subjected to further purification and separation by chromatographic separation techniques to enhance its purity and to remove contaminants there from. This process provides an access to a fraction enriched in 10-100% AKBA for therapeutic applications.
The European patent publication EP1637153A1 relates to the association of Boswellia Serrata extract with plant antifibrotic agent as medicament particularly against inflammatory and fibrotic courses. In such association Boswellia Serrata is present as dry extract in quantity from 5 to 50% and the plant antifibrotic agent as dry extract in quantity from 50 to 95% by weight.
The U.S. patent U.S. Pat. No. 5,629,351 relates to a novel fraction comprising a mixture of boswellic acids, wherein the fraction exhibits anti-inflammatory and antiulcerogenic activities. Also disclosed is a novel boswellic acid compound exhibiting anti-inflammatory, antiarthritic and antiulcerogenic activities. Also disclosed is a process for isolating a boswellic acid fraction and individual boswellic acids therefrom.
The U.S. patent U.S. Pat. No. 5,720,975 relates to the use of incense (olibanum), incense extracts, substances contained in incense, their physiologically acceptable salts, their derivatives and their physiological salts, pure boswellic acid, of physiologically acceptable salts, of a derivative, of a salt of the derivative, for production of a medicament for the prevention or treatment of Alzheimer's disease.
The U.S. patent U.S. Pat. No. 5,888,514 refers to a composition for treating a mammal having a condition characterized by bone or joint inflammation where extract of Boswellia serrata is used as one of the ingredients.
The PCT patent publication WO08036932A2 relates to compositions and methods, for making compositions derived from Boswellia species (frankincense or olibanum) having uniquely elevated volatile oil, boswellic acids, and polysaccharide compounds, particularly, human oral delivery formulations, and methods for use of such compositions, useful e.g. for treating/preventing arthritis, inflammatory disorders, osteoarthritis, rheumatoid diseases and low back pain.
There is however no prior art, to the best of inventors knowledge, relating to the compositions comprising Boswellia extract especially AKBA enriched extract along with Boswellia serrata non-acidic resin extract (BNRE) for the prevention, control and treatment of inflammatory conditions.